PROton Therapy for Post Surgical Treatment of GYNecologic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
This is a single institution, multi-center, Phase II, single-arm study, using Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) in the post-surgical, adjuvant setting for definitive treatment of gynecologic cancers. The purpose of this study is to estimate rate of acute clinician-reported gastrointestinal (GI) toxicity using WP PBS PRT in the definitive treatment of gynecologic cancers in the post-surgical, adjuvant setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed cervical or endometrial cancer
Indication for adjuvant whole pelvic radiation therapy, with or without systemic therapy
Age of 18 years or older
Written informed consent
Disqualifiers
Prior course of pelvic radiation
Metastatic disease outside of the pelvis
Active inflammatory bowel disease
Incapacity to provide informed consent
Trial design
Design model
Single group
Treatments tested in this trial
Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)
RadiationThe study intervention is Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT) as part of the definitive treatment of gynecologic cancers in the post-hysterectomy, adjuvant setting. Patients will be treated with doses of 45 or 50.4 Gy in 1.8 Gy daily fractions. The volume treated will include the whole pelvis according to Radiation Therapy Oncology Group post-hysterectomy pelvis guidelines.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Adjuvant Whole Pelvis (WP) Pencil Beam Scanning Proton Radiation (PBS PRT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Acute clinician-reported gastrointestinal (GI) toxicity.
Determine the rate of acute clinician-reported gastrointestinal (GI), with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria. Acute GI grade 2 or higher toxicity is the primary powering endpoint.
Time frame
Up to 6 months after end of treatment at follow up visitsSecondary outcomes
1
Acute clinician-reported genitourinary (GU) toxicity.
Determine the rate of the acute clinician-reported genitourinary (GU) toxicity, with the Common Terminology Criteria for Adverse Events (CTCAE v5.0) criteria.
Time frame
Up to 6 months after end of treatment at follow up visits2
Acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life.
Determine the rate of acute patient-reported gastrointestinal (GI) and genitourinary (GU) toxicity and quality of life using the EPIC urinary and bowel score (expanded prostate cancer index composite) and FACT-Cx.
Time frame
Up to 6 months after end of treatment at follow up visits3
Loco-regional recurrence free survival, disease free survival, and overall survival.
Determine loco-regional recurrence free survival, disease free survival, and overall survival.
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov